DRUG FORM: Coated tablets.
PHARMACOLOGICAL GROUP: calcium-channel blocker dihydropyridine produced.
COMPOSITION: Active substance: Nifedipine -10mg.
Aiding substances: lactose monohydrate, microcrystalline cellulose, corn starch, polyvinylpyrrolidone, calcium or magnesium stearate, saccharose, magnesium carbonate, talcum, yellow pigment, titanium dioxide, aerosil.
PHARMACOLOGICAL OPERATION: Nifedipine is produced by chemical structure of 1,4 dihydropyridine. It is calcium-channel selecting blocker. The preparation is characterized by vasodilatation, antianginal and antihypertensive action. Calcium-channel blocker, Nifedipine slows calcium ions’ transmembrane availability in arteries and cardiac hystiocyte smooth muscular cells. By its influence there is reduced blood-vessel walls tonus, extents peripheral and coronal artery; reduces vessels total peripheral resistance and blood pressure. By lowering of coronal artery smooth muscle tonus, development of coronary vasospasm is avoided. At the expense of reduction of vessels total peripheral resistance, request of myocardium for oxygen reduced. As a response of peripheral vasodilatation, sympathoadrenal system reflex activation takes place, which covers negative chronotropic, dromotropic and inotropic effect of the preparation. By this reason “Nifedipin Neo” doesn’t cause orthostatic actions development. The preparation mostly influences on blood vessel muscles, less- heart patulous system. Long use of preparation causes excretion of sodium ions and water. Preparation is effective after 20 minutes from taking and continues for 4-6 hours.
Pharmacokinetics: After peroral intake “Nifedipin” is quickly and wholly (90%) absorbed from gastrointestinal tract. Bioavailability makes up 60-75%. 90% of the preparation relates to proteins. Maximum concentration in plasma is mentioned after 1-3 hours. Passes hematoencephalic and placental barrier, excreted with breast milk, metabolizes in the liver. Inactive metabolites are excreted by the kidneys (70-80%). Semiejection period 2-4 hours. Kidneys’ chronic insufficiency, hemodialysis and peritoneal dialysis don’t influence on preparation pharmacokinetics. In case of its long term use (2-3 months) there is developed tolerance toward the preparation.
INDICATION:it is used in complex therapy, as an aid mean:
· Essential hypertension (like monotherapy or in combination of other antihypertensive drugs);
· Hypertensic crisis;
· Classic vasospastic stenocardia (Prinzmetal’s angina) or coronary artery spasm confirmed by angiography;
· Chronic, stable stenocardia (in this case is recommended to take “Nifedipin” in combination with beta blocker);
· Raynaud’s disease.
DOSAGE REGIME: Dosage is individual according to disease hardness and patient’s reaction on the preparation. Preparation intake is recommended before eating with small amount of water.
In case of vasospastic stenocardia is prescribed: 1-2 pills (10-20 mg.) three times a day;
In case of chronic stable stenocardia: 1-2 pills three times a day;
In case of essential hypertension: 1-2 pills three times a day;
Maximum daily dose – 6 pills (60mg.). In case of hypertensic crisis it is possible to chew the pill for a quick effect, keep for a while in the mouth and swallow together with small amount of water. In case of insufficient effect you can repeat the same after 30 minutes.
For elderly and diseased people – combination therapy (antianginal and hypotensive), also patients with kidney functional disorder and blood circulation disorder in the brain, dosage decrease is necessary.
In case of dosage skipping double dose mustn’t be taken. Treatment should be continued according to primary schedule. Duration of treatment is determined by the doctor.
SIDE EFFECTS: “Nifedipin” is usually well tolerated. Majority of side effects are caused by the expansion of cardiovascular activity and disappears after stop treatment. In most cases there may develop the following side effects: skin hyperemia, redness, flush and headache caused by cerebrum vessels tonus lowering and lift because of blood flow increase. In such case dose of “Nifedipin” should be reduced or it should be taken after eating.
Allergic reactions: rash on the skin, itch.
From the side of digestion system: nausea, heartburn, diarrhea, dry mouth.
From the side of central and peripheral system: headache, dizziness, limb paresthesia, pain in muscles, sleep disturbance (long use of great doses).
· Hypersensitivity toward components of “Nifedipin” or other compounding components.
· Hypovolemia (reduction of blood being in circulation).
· Instable stenocardia.
· Transferred cardiac infarction.
· Pregnancy and lactation period.
· Simultaneous intake together with Rifampicin (efficiency of “Nifedipin” decreases significantly).
· Hard heart failure.
· Hard aortal stenosis.
Symptoms: bradycardia, bradyarrhythmia, sharp decrease of arterial pressure, in hard condition – collapse, headache, pain in the chest area, increase of sugar in blood.
In case of overdose address to doctor immediately!
For excretion of preparation from the organism there should be taken following measures: gastric lavage, intake of activated charcoal.
Symptomatic treatment should be carried out for cardiovascular system stabilization (calcium gluconate, dopamine or dobutamine, adrenaline, norepinephrine, atropine), hemodialysis is less effective, plasmapheresis is recommended.
INTERACTION WITH OTHER THERAPEUTIC AGENTS: “Nifedipin” intake together with antihypertensive agents causes effect strengthening. Taking together with nitrate strengthens tachycardia and hypotensive action. Simultaneous intake of “Nifedipin” and beta blockers must be under doctor’s supervision, as blood pressure sharp lowering may develop and in some cases exacerbation of heart failure symptoms. “Nifedipin” lowers quinidine concentration in plasma. Increases concentration of digoxin and theophylline and their concentration control in plasma is necessary. Rifampicin decreases efficiency of “Nifedipin” (accelerates its metabolism at the expense of liver enzyme activity induction). Interaction with Prazosinum may cause sharp lowering of blood pressure. Simultaneous intake together with tricyclic antibiotics, cimetidine, Ranitidine strengthens efficiency of “Nifedipin”. Taking together with Phenytoin, availability of “Nifedipin” in the organism lowers and accordingly – efficiency, therefore increase of dose may be needed. As “Nifedipin” metabolises by means of liver enzyme system, therapeutic agents which suppress or strengthen enzyme activity, influence on “Nifedipin” operation.
SPECIAL INSTRUCTIONS: During treatment it is necessary to abstain from alcohol intake. In spite of the fact that the preparation doesn’t characterize removal syndrome, termination of treatment is recommended with gradual reduction of dose.
It is necessary to use “Nifedipin” with care to those patients, whose systolic arterial pressure is less than 90 mm.
If revealed chest pain during the treatment is related to preparation intake.
Use of “Nifedipin” is extremely risky for patients with congestive heart failure.
PREGNANCY AND LACTATION PERIOD: Usage of preparation is not recommended during the period of pregnancy and lactation.
INFLUENCE OF VEHICLE AND MECHANISMS MANAGEMENT: The preparation doesn’t influence on attention concentration, however in some cases may reduce arterial pressure, so it is necessary to be careful during management of motor transport and mechanisms.
DRUG RELEASE FORM: Primary package: N 20 pills on a pvc/alu blister.
Secondary package: 2 blisters in the box.
ORDER OF ISSUE FROM PHARMACY: II group of pharmaceutical product, issued with prescription N3 (for emergency medical care is issued without a prescription).
STORAGE CONDITIONS: Store at 15-25ºC temperature, in a dry, protected from light place and keep away from children.
DATE OF EXPIRE: 2 years.
Do not use preparation after expire or in case of visual defect.
PRODUCER: “Neopharmi” LTD.

Davit Aghmashenebeli alley 12 km, Tbilisi, Georgia.